Protocol for an Open Labelled Randomised Comparative Clinical Study to Evaluate Efficacy of Vangashilajatu and Nishaamalaki in the Management of Madhumeha (T2DM)

Abstract

Background: Madhumeha, described in Ayurveda under Vataja Prameha, closely resembles Type 2 Diabetes Mellitus (T2DM), a chronic metabolic disorder characterized by persistent hyperglycaemia. Ayurveda advocates various therapeutic approaches including herbal formulations, dietary regulation, lifestyle modifications, and Yoga for its management. Although Vangashilajatu and Nishaamalaki are widely used in the treatment of Madhumeha, comparative clinical evidence regarding their efficacy remains limited. Objective: To evaluate and compare the clinical efficacy and safety of Vangashilajatu and Nishaamalaki in the management of Madhumeha (T2DM). Methods and Design: This prospective, single-centre, open-labelled, randomized comparative clinical trial will include 60 patients aged 25–60 years diagnosed with Madhumeha. Eligible participants will be randomly allocated into two groups. Group A will receive Vangashilajatu, while Group B will receive Nishaamalaki. Both groups will receive appropriate Pathya-Apathya advice and treatment for 28 days. Clinical assessments will be performed on the 7th, 14th, 21st, and 28th day during treatment and on the 42nd and 56th day during post-treatment follow-up. Expected Results: Primary outcomes will include changes in the cardinal signs and symptoms of Madhumeha described in Ayurvedic texts. Secondary outcomes will assess changes in fasting blood sugar, post-prandial blood sugar, HbA1c, and overall quality of life. Conclusion: This study is expected to generate comparative clinical evidence regarding the efficacy of Vangashilajatu and Nishaamalaki in Madhumeha. Both formulations are anticipated to improve clinical symptoms and blood sugar parameters; however, Vangashilajatu is hypothesized to yield a superior efficacy and may serve as an effective Ayurvedic intervention for the management of Madhumeha (T2DM).

Introduction

The text presents a clinical study comparing two Ayurvedic formulations—Vangashilajatu and Nishaamalaki—for the management of Madhumeha (Type 2 Diabetes Mellitus).

Background

In Ayurveda, Madhumeha is considered a complex form of Vataja Prameha involving multiple Doshas, Dushyas, and Srotas. Its characteristic features include excessive and turbid urination. Madhumeha is described as developing either due to Dhatukshaya or obstruction of Vata caused by aggravated Kapha and Meda.

Madhumeha is considered comparable to Type 2 Diabetes Mellitus (T2DM), a metabolic disorder associated with chronic high blood glucose and disturbances in carbohydrate, fat, and protein metabolism. Major risk factors include sedentary lifestyle, unhealthy diet, obesity, and genetic predisposition. Diabetes is a major global health concern, with the text reporting a prevalence of 15.1% in Haryana and approximately 537 million adults living with diabetes globally in 2021.

Purpose of the Study

Ayurveda provides several formulations for managing Madhumeha. The study focuses on:

• Vangashilajatu, containing Shuddha Shilajatu and Vanga Bhasma.
• Nishaamalaki, containing Haridra (Turmeric) and Amalaki.

Although individual studies have examined these formulations, the text states that no comparative clinical study between Vangashilajatu and Nishaamalaki had been reported. Therefore, the study aims to compare their effectiveness in patients with Madhumeha, particularly T2DM.

Methodology

The study is designed as an open-label, randomized, parallel-group comparative clinical trial.

• Participants: 60 patients with Type 2 Diabetes Mellitus.
• Group A: 30 patients receiving Vangashilajatu.
• Group B: 30 patients receiving Nishaamalaki.
• Study location: P.G. Department of Kayachikitsa, Institute for Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra, Haryana.
• Randomization: Computer-generated random allocation.
• Treatment duration: 28 days.
• Follow-up: Assessments continue until Day 56.

Patient Selection

Participants are adults aged 25–60 years who meet the diagnostic criteria for T2DM and have:

• Fasting Blood Sugar (FBS): 126–200 mg/dL
• Post-Prandial Blood Sugar (PPBS): 200–300 mg/dL
• HbA1c: 6.5–8%

Patients with conditions such as Type 1 diabetes, gestational diabetes, severe diabetic complications, pregnancy, or severe hepatic, renal, cardiovascular, or malignant diseases are excluded.

Treatments

Group A – Vangashilajatu

Patients receive one capsule twice daily, 15 minutes before meals for 28 days. Each capsule contains:

• Vanga Bhasma – 125 mg
• Shuddha Shilajatu – 250 mg

Group B – Nishaamalaki

Patients receive 3 g of Nishaamalaki Churna twice daily, 15 minutes before meals for 28 days. It contains equal proportions of:

• Nisha (Curcuma longa/Haridra)
• Amalaki (Emblica officinalis)

Study Procedure and Assessment

Patients are assessed at Day 0, 7, 14, 21, 28, 42, and 56. Clinical symptoms, vital signs, treatment compliance, and adverse effects are recorded.

Laboratory assessment includes:

• Fasting Blood Sugar (FBS)
• Post-Prandial Blood Sugar (PPBS)
• HbA1c

Subjective Ayurvedic symptoms are also assessed using predefined scales, including urine turbidity (Aavila Mutrata) and other classical features of Madhumeha.

Ethical Considerations

The study received approval from the Institutional Ethics Committee of Shri Krishna AYUSH University, Kurukshetra and was registered with the Clinical Trials Registry–India (CTRI). Written informed consent is obtained from all participants, and participants can withdraw from the study at any time.

Conclusion

This study protocol details an open labelled, parallel comparative clinical trial aimed at evaluating the efficacy and safety of Vangashilajatu versus Nishaamalaki in patients with Madhumeha (TYPE 2 DM). Successful results could pave the way for evidence based integration of Ayurvedic treatment modalities into modern healthcare practice. A. Funding Sources Funding: This research is supported by the financial allotment from the Institute for Ayurved Studies & Research, Faculty of Ayurved, Kurukshetra. B. Conflict of Interest The authors declare no conflict of interest. C. Declaration of generative AI in scientific writing The authors have not used any AI tools for writing this manuscript. D. Acknowledgments The authors acknowledge the support of the Pharmacy/Ras Shastra & Bhaishajya Kalpana Department, the Central Research Laboratory at Shri Krishna AYUSH University, and the Pathology Laboratory at the Institute for Ayurved Studies & Research.

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Copyright

Copyright © 2026 Dr. Himani Bhardwaj, Dr. Neelam Kumari, Dr. Neha Lamba. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.